SAMPLING KIT FOR THE TRANSPORT OF SPUTUM

Abstract

There was still an unsatisfied need to have a device specifically adapted for the collection of sputum, for example from CF patients. This technical problem is overcome by the kit of the invention comprising a sterile sampling container having a gas-permeable cap, an anaerobic atmosphere generator, and a sealable pouch adapted to receive the sterile sampling container and the anaerobic atmosphere generator therein. This kit is easy to use, cost effective and makes the transport of the sample easy while the sample can be kept viable for several hours. Our in vitro tests show that the use of the kit improves the number of survival colonies by 3 log after 48 h for V. parvula and by 1 log after 24 h for S. aureus.

Claims

1. A kit for collecting and transporting a sputum sample of a patient comprising: a sterile sampling container having a gas-permeable cap, an anaerobic atmosphere generator, and a sealable pouch configured to receive the sterile sampling container and the anaerobic atmosphere generator therein.

2. The kit according to claim 1, wherein the sealable pouch is made of plastic and is impermeable to oxygen.

3. The kit according to claim 1, further comprising a sealer configured to seal and unseal the sealable pouch without destruction of the sealable pouch.

4. The kit according to claim 3, wherein the sealer comprises a tube with a slit extending from one end of the tube to the other end thereof and a cylinder fitted inside the tube.

5. The kit according to claim 1, wherein the anaerobic atmosphere generator is a solid CO.sub.2 generator, optionally contained in a sachet.

6. The kit according to claim 1, wherein the sterile sampling container has a capacity comprised between 5 and 100 mL.

7. The kit according to claim 1, wherein the sterile sampling container is made of thermoplastic.

8. The kit according to claim 1, wherein the gas permeable cap is a screwable cap.

9. A method for collecting a sputum sample of a patient, comprising the steps of: collecting the sputum sample in a sterile sampling container, closing the sterile sampling container with a gas permeable cap, enclosing the closed sterile sampling container and an anaerobic atmosphere generator in a sealable pouch, and sealing the sealable pouch.

10. The method according to claim 9, wherein the step of enclosing step comprises first placing the sterile sampling container comprising the sputum sample inside the sealable pouch and then placing the anaerobic atmosphere generator inside the sealable pouch thereafter.

11. The method according to claim 9, wherein the step of sealing comprises sealing the pouch with a sealer which seals and unseals the sealable pouch without destruction thereof.

12. The method according to claims 9, wherein the step of collecting further comprises collecting the sputum in a sterile spit jar, and transferring the collected sputum into the sterile sampling container with a sterile pipet.

13. The kit according to claim 6, wherein the sterile sampling container has a capacity of from 25 to 75 mL.

14. The kit according to claim 7, wherein the thermoplastic is polypropylene.

Description

BRIEF DESCRIPTION OF DRAWINGS

[0081] Other features, details and advantages will be shown in the following detailed description and on the illustrative and non-limiting figures:

[0082] FIG. 1 is a scheme of an open sealable pouch comprising a sterile sampling container having a gas-permeable cap and an anaerobic atmosphere generator.

[0083] FIG. 2 is a scheme of a sealed pouch comprising a sterile sampling container having a gas-permeable cap and an anaerobic atmosphere generator.

[0084] FIG. 3 is an example of a sealer according to the present invention.

[0085] FIG. 4 is a graph showing the quantification of Veillonella parvula colonies (in UFC/mL) in a sampling container preserved in anaerobic or aerobic atmosphere during 48 h, in comparison with the quantification before the bacteria are placed in the sampling container (initial counting at t=0).

[0086] FIG. 5 is a graph showing the quantification of Staphylococcus aureus colonies (in UFC/mL) in a sampling container preserved in anaerobic or aerobic atmosphere during 24 h, in comparison with the quantification before the bacteria are placed in the sampling container (initial counting at t=0).

DESCRIPTION OF EMBODIMENTS

[0087] A kit for collecting and transporting a sputum sample of a patient is now described in detailed with regard to FIGS. 1 and 2.

[0088] The kit comprises: [0089] a sterile sampling container 40 having a gas-permeable cap 45, [0090] an anaerobic atmosphere generator 20, and [0091] a sealable pouch 10 adapted to receive the sterile sampling container 40 and the anaerobic atmosphere generator therein 20.

[0092] The sterile sampling container 40 is a tube of 50 mL made of polypropylene. It has on its side a plurality of lines indicating the capacity of the tube. One end of the tube has a decreasing diameter so that one end of the tube is a truncated cone.

[0093] The gas-permeable cap 45 is a solid cap with holes on its upper face. The gas-permeable cap 45 is also a screwable cap. The screwable cap 45 is screwed on the tube on the opened side opposite to the truncated cone.

[0094] The sealable pouch 10 is transparent, flexible and made of plastic. The sealable pouch 10 has a rectangular geometry with one width being open.

[0095] The opened side of the sealable pouch 10 is sealed with a sealer 30 in the form of a tube.

[0096] It is now made reference to the FIG. 3. The sealer 30 comprises a tube 44 with a slit extending from one end of the tube 44 to the other end thereof and a cylinder 33 fitted inside the tube 44. To close the sealable pouch 10, the sealable pouch 10 is wrapped around the cylinder 33. The cylinder 33 is then placed inside the tube 44 so that the sealable pouch is sealed.

[0097] The anaerobic atmosphere generator 20 is a CO.sub.2 generator contained in a sachet made of a porous material. The anaerobic atmosphere generator 20 is kept in a metallic packaging avoiding any contact between the anaerobic atmosphere generator 20 and air. Depending on the anaerobic atmosphere generator used, the sachet may reduce the oxygen content in the pouch to below 1% within 30 minutes. The resulting carbon dioxide content will be between 8 and 14%.

Qualitative Validation of the Sampling Kit

[0098] A qualitative validation of the kit according to the preferred embodiment of the present invention was done to ensure that an anaerobic atmosphere is successfully generated in the pouch.

[0099] Strips of resazurin (a colored redox indicator which is pink when in contact with oxygen) are placed in ten sterile sampling containers.

[0100] Each of the ten containers is closed with a screwable gas permeable cap. The closed containers comprising the strip of resazurin are then placed in sealable pouches.

[0101] Anaerobic atmosphere generators are then placed in each pouch. The ten pouches are finally sealed with sealers as the one shown in FIG. 2.

[0102] The strips of resazurin disposed in the kit have lost their pink colour approximately 3 hours after the pouch was sealed.

[0103] Thus, the kit can be effectively used for the transport of sputum sample.

Quantitative Validation of the Sampling Kit

[0104] A quantitative validation of the kit according to the preferred embodiment of the present invention was done to ensure that the sample can be successfully kept viable for several hours.

[0105] Defined number of colonies of strictly anaerobic bacteria V. parvula and aero-anaerobic S. aureus are placed into a sterile sampling container closed with a gas permeable cap. The closed container is then placed with the anaerobic atmosphere generator into a pouch. The pouch is finally sealed with a sealer as shown in FIG. 2.

[0106] The colonies of strict anaerobic bacteria V. parvula are kept for 48 hours in the anaerobic atmosphere within the sealable pouch.

[0107] After 48 h, counting of the colonies of bacteria according to usual method is done to check the viability of the anaerobic atmosphere inside the sealed pouch.

[0108] As it can be seen in FIG. 4, after 48 h in the kit according to an embodiment of the present invention, the number of colonies slightly decrease from 1 E+07 UFC/mL to approximately 1.5E+06 UFC/mL. In contrast, the number of colonies drastically decreases after 48 h in the kit in an aerobic atmosphere from 1 E+07 UFC/mL to approximately 1 E+03 UFC/mL. Therefore, the loss of bacteria was only 1 log with the kit of the invention and 4 log otherwise.

[0109] It has thus been demonstrated that the present invention makes it possible to keep a sputum sample comprising strict anaerobic bacteria viable for at least 48 h.

[0110] The colonies of aero-anaerobic bacteria S. aureus are kept for 24 hours in the anaerobic atmosphere within the sealable pouch.

[0111] As it can be seen in FIG. 5, after 24 h in the kit according to an embodiment of the present invention, the loss of bacteria was only 1 log. In contrast, the increase of the number of colonies after 24 h in an aerobic atmosphere was 2 log.

[0112] It has thus been demonstrated that the present invention makes it possible to stop the proliferation of aero-anaerobic bacteria and keeps a sputum sample comprising aero-anaerobic bacteria viable for at least 24 h.